Operation Warp Speed (OWS), the Trump administration's bold effort to deliver at least 300 million doses of a safe and effective coronavirus vaccine by January, took another expensive step forward. On Friday, Sanofi (NASDAQ:SNY) and GlaxoSmithKline (NYSE:GSK) signed a vaccine-supply deal with the U.S. government worth up to $2.1 billion to help the collaboration partners scale up manufacturing of a vaccine candidate -- before there are clinical-trial results that prove it safely prevents SARS-CoV-2, the virus that causes COVID-19, from spreading.
Bottomless expense accounts have allowed the leading vaccine candidates to advance at top speed. Here's a quick rundown to help you keep tabs on the top five programs and the funds that are pushing them forward.
|Company (Symbol)||OWS Funding||Phase 3 Start Date|
|Sanofi and GlaxoSmithKline||$2.1 billion||End of 2020|
|BioNTech SE (NASDAQ:BNTX) and Pfizer (NYSE:PFE)||$2 billion||July 27, 2020|
|Novavax (NASDAQ:NVAX)||$1.6 billion||Fall 2020|
|AstraZeneca (NASDAQ:AZN)||$1.2 billion||June 20, 2020|
|Moderna (NASDAQ:MRNA)||$955 million||July 27, 2020|
Who needs a name?
Sanofi and GlaxoSmithKline are committed to developing a coronavirus vaccine candidate at top speed but haven't yet bothered to give their protein-based vaccine candidate a name. Sanofi will provide the partnership with a protein that mimics part of SARS-CoV-2, and GlaxoSmithKline will contribute an adjuvant designed to spark a stronger immune response to Sanofi's protein.
The government has promised the partners up to $2.1 billion, around half of which will pay for clinical trials that aren't expected to begin until the fall. If a phase 1/2 study planned to begin in September produces encouraging results, a phase 3 trial could start by the end of 2020.
Sanofi and GlaxoSmithKline will use the remaining portion of committed funding to support the manufacturing of their vaccine candidate. The partners will produce 100 million doses long before it has a chance to prove itself effective. The government also has an option for the supply of an additional 500 million doses down the road.
BNT162 from BioNTech and Pfizer
In partnership with Pfizer, BioNTech is one of two clinical-stage biotechs with OWS-backed vaccine programs that rely on strands of messenger RNA (mRNA) that get human cells to produce proteins that mimic SARS-CoV-2. Unlike the other mRNA program, mRNA1273 from Moderna, BNT162 entered phase 1 testing as multiple related candidates.
When the government placed an initial order for 100 million doses with an option to buy another 500 million, the partners hadn't selected the specific candidate they would move into phase 3 testing yet. Shares of BioNTech vaulted higher when the company reported encouraging signs of efficacy from BNT162b1 in early July, but the partners began a phase 2b/3 trial with BNT162b2 because patients who received it were less likely to report fever, fatigue, and chills.
NVX-CoV2373 from Novavax
This Maryland-headquartered biotech company has been developing vaccines since the 1980s but still hasn't sent any new drug applications to the Food and Drug Administration (FDA). Despite this troubling track record, the government has purchased 100 million doses of NVX-CoV2373, the company's SARS-CoV-2 vaccine candidate, for delivery in late 2020
In July, OWS granted Novavax a $1.6 billion award that the company will use to complete the late-stage development of NVX-CoV2373. This is an adjuvant-boosted protein similar to the candidate Sanofi and GlaxoSmithKline are testing.
During the first week of August, Novavax will share results from a 130-patient phase 1/2 clinical trial that began in May. The company expects to begin a phase 3 study that will enroll up to 30,000 people in the fall.
AZD1222 from AstraZeneca
This is one of three OWS-backed vaccine candidates that use the carved-out husk of another virus to deliver genetic material that cells use to produce proteins found on SARS-CoV-2. AstraZeneca's partners at Oxford University began a phase 3 trial with AZD1222 in Brazil, all the way back on June 20, 2020.
The ongoing 5,000-patient phase 3 study in Brazil was sponsored entirely by concerned Brazilian entrepreneurs, but the U.S. government will fund a phase 3 study with 30,000 patients, which is expected to begin soon. In addition to a giant pivotal study, AstraZeneca will also use up to $1.2 billion of taxpayer dollars to produce 400 million doses for the U.S., making it the least expensive vaccine OWS has backed so far.
mRNA-1273 from Moderna
In April, Moderna received a $483 million commitment to support the development of its mRNA-based vaccine candidate, mRNA-1273. In July, the company received a $483 million top-up to run a much larger phase 3 trial than originally intended.
Before results of the 30,000-participant Cove study are complete, the company will use its OWS award to scale up manufacturing. Moderna thinks it will be able to deliver up to 1 billion doses of mRNA-1273 annually in 2021.
So much more
It might feel like forever, but the COVID-19 pandemic will end in the foreseeable future, along with any cash flows these vaccines might produce. Investing in any of these companies simply because there could be a large (but short) windfall in their near future probably isn't a great idea.
While the amount of demand for a SARS-CoV-2 vaccine is unprecedented, so is the level of competition. In addition to these five well-funded programs, at least a dozen more will produce their first clinical-trial results by the end of the summer.